BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 1.8ML

    MDR report key: 4223314 · Received November 4, 2014

    Report

    Report Number
    2032227-2014-46764
    Event Type
    Malfunction
    Date Received
    November 4, 2014
    Date of Event
    October 5, 2014
    Report Date
    October 5, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K001828
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. WE THEREFORE CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.(B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER'S RESERVOIR WAS NOT ABLE TO DELIVER INSULIN WHEN HE PLACED IT ON THE INSULIN PUMP. THE CUSTOMER REFUSED TROUBLESHOOTING. THE CUSTOMER'S BLOOD GLUCOSE WAS 98 MG/DL. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    706443 RESERVOIR 1.8ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-326A H9026307

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR